(a) Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.

(b) An individual who is at least 18 years of age may apply for a designated representative-reverse distributor license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:

Terms Used In California Business and Professions Code 4053.2

  • board: means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or registration authorizing a person to engage in a business or profession. See California Business and Professions Code 31
  • license: means license, certificate, registration, or other means to engage in a business or profession regulated by this code or referred to in Section 1000 or 3600. See California Business and Professions Code 23.7

(1) The individual shall be a high school graduate, possess a general education development certificate equivalent, or have earned a degree from an accredited postsecondary institution.

(2) The individual shall meet one of the following requirements:

(A) Have a minimum of one year of paid work experience in the past three years with a licensed wholesaler, third-party logistics provider, or pharmacy performing duties related to the distribution, dispensing, or destruction of dangerous drugs or dangerous devices.

(B) Have a minimum of one year of paid work experience in the destruction of outdated or nonsaleable dangerous drugs or dangerous devices pharmaceutical waste.

(C) Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.

(3) (A) The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:

(i) Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.

(ii) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.

(iii) Knowledge and understanding of California law and federal law relating to the removal and destruction of dangerous drugs, dangerous devices, and pharmaceutical waste.

(iv) Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.

(B) The board may, by regulation, require the training program required under this paragraph to include additional material.

(C) The board shall not issue a license as a designated representative-reverse distributor until the applicant provides proof of completion of the training required by this paragraph to the board.

(c) A reverse distributor shall not operate without at least one designated representative or designated representative-reverse distributor present at each of its licensed places of business as required under Section 4160.

(Amended by Stats. 2021, Ch. 629, Sec. 15. (AB 1533) Effective January 1, 2022.)

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